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Fda Cder Jobs (NOW HIRING)

Ivyhill Technologies

Computer Operator II

Rockville, MD · On-site

Ivyhill has an immediate need for a Computer Operator II that will support our their FDA CDER DCC project in Rockville, MD. The Computer Operator II (CO2) will process scheduled routines that present ...

Ardelyx

Senior Director, Regulatory Affairs

Waltham, MA

$259K - $317K/yr

Lead interactions with FDA (CDER/CBER/CDRH as applicable), EMA, and other global health authorities, including Type A/B/C meetings, Scientific Advice, and Innovation Office engagements * Partner with ...

Ardelyx

Senior Director, Regulatory Affairs

Waltham, MA · On-site

$259K - $317K/yr

Lead interactions with FDA (CDER/CBER/CDRH as applicable), EMA, and other global health authorities, including Type A/B/C meetings, Scientific Advice, and Innovation Office engagements * Partner with ...

Ardelyx

Senior Director, Regulatory Affairs

Newark, CA

$259K - $317K/yr

Lead interactions with FDA (CDER/CBER/CDRH as applicable), EMA, and other global health authorities, including Type A/B/C meetings, Scientific Advice, and Innovation Office engagements * Partner with ...

Ardelyx

Senior Director, Regulatory Affairs

Newark, CA

$259K - $317K/yr

Lead interactions with FDA (CDER/CBER/CDRH as applicable), EMA, and other global health authorities, including Type A/B/C meetings, Scientific Advice, and Innovation Office engagements * Partner with ...

Ardelyx

Senior Director, Regulatory Affairs

Waltham, MA · On-site

Lead interactions with FDA (CDER/CBER/CDRH as applicable), EMA, and other global health authorities, including Type A/B/C meetings, Scientific Advice, and Innovation Office engagements * Partner with ...

Ardelyx, Inc.

$259 - $317/hr

Lead interactions with FDA (CDER/CBER/CDRH as applicable), EMA, and other global health authorities, including Type A/B/C meetings, Scientific Advice, and Innovation Office engagements * Partner with ...

New

Ardelyx

Senior Director, Regulatory Affairs

Newark, CA · On-site

$259K - $317K/yr

Lead interactions with FDA (CDER/CBER/CDRH as applicable), EMA, and other global health authorities, including Type A/B/C meetings, Scientific Advice, and Innovation Office engagements * Partner with ...

Ardelyx

Senior Director, Regulatory Affairs

Newark, CA · On-site

Lead interactions with FDA (CDER/CBER/CDRH as applicable), EMA, and other global health authorities, including Type A/B/C meetings, Scientific Advice, and Innovation Office engagements * Partner with ...

Ardelyx

Senior Director, Regulatory Affairs

Waltham, MA

$259K - $317K/yr

Lead interactions with FDA (CDER/CBER/CDRH as applicable), EMA, and other global health authorities, including Type A/B/C meetings, Scientific Advice, and Innovation Office engagements * Partner with ...

Ardelyx

Senior Director, Regulatory Affairs

Newark, CA · On-site

$259K - $317K/yr

Lead interactions with FDA (CDER/CBER/CDRH as applicable), EMA, and other global health authorities, including Type A/B/C meetings, Scientific Advice, and Innovation Office engagements * Partner with ...

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Fda Cder information

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$34.5K

$78.4K

$127K

How much do fda cder jobs pay per year?

As of Aug 23, 2026, the average yearly pay for fda cder in the United States is $78,419.00, according to ZipRecruiter salary data. Most workers in this role earn between $61,000.00 and $90,500.00 per year, depending on experience, location, and employer.

What is an FDA CDER?

An FDA CDER job refers to a role within the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). CDER is responsible for ensuring the safety, effectiveness, and quality of human drugs. Jobs in CDER can include roles in drug review, regulatory science, pharmacology, and policy development. Employees work to evaluate new drug applications, monitor post-market drug safety, and develop guidelines to improve public health. Positions may require expertise in medicine, pharmacy, biology, chemistry, or regulatory affairs.

What are the typical daily responsibilities of someone working at FDA CDER?

At FDA CDER, typical daily responsibilities include reviewing data from drug development and clinical trials, preparing and assessing regulatory submissions, and collaborating closely with colleagues across scientific, legal, and public health disciplines. Professionals may participate in meetings to discuss safety or efficacy issues, draft guidance documents, and respond to inquiries from pharmaceutical companies. Teamwork and cross-disciplinary communication are frequent given the complexity of regulatory decisions. The work is highly detail-oriented and focuses on ensuring that medications are safe and effective for public use.

What are the key skills and qualifications needed to thrive in the FDA CDER position, and why are they important?

To thrive in a role within the FDA's Center for Drug Evaluation and Research (CDER), you typically need a background in pharmaceutical sciences, regulatory affairs, medicine, or related scientific fields, often with an advanced degree such as a PharmD, PhD, or MD. Familiarity with regulatory guidelines (e.g., FDA, ICH), submission management systems, and data analysis tools is commonly required, along with certifications like RAC (Regulatory Affairs Certification) being beneficial. Exceptional analytical thinking, attention to detail, and effective written and verbal communication skills help professionals excel in multidisciplinary team settings. These competencies are essential for ensuring thorough drug evaluation, compliance with regulations, and safeguarding public health.

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Fda Cder jobs near you
Infographic showing various Fda Cder job openings in the United States as of August 2026, with employment types broken down into 94% Full Time, and 6% Contract. Highlights an 49% In-person, 13% Hybrid, and 38% Remote job distribution, with an average salary of $78,419 per year, or $37.7 per hour.

Computer Operator II

Ivyhill Technologies

Rockville, MD • On-site

Other

Medical, Dental, Vision, Life, Retirement

Re-posted 14 days ago

Job description

Ivyhill has an immediate need for a Computer Operator II that will support our their FDA CDER DCC project in Rockville, MD. The Computer Operator II (CO2) will process scheduled routines that present few difficult operating problems (e.g., infrequent or easily resolved error conditions). In response to computer output instructions or error conditions, the CO2 applies standard operating or corrective procedures, refers problems that do not respond to pre-planned procedures, and may serve as an assistant operator, working under general supervision.

Key Responsibilities:

  • Receive, process, and load physical electronic submissions to an electronic repository
  • Handle electronic file maintenance and maintain file storage
  • Load emails, notifications, and files to a tracking IT system
  • Perform a quality review of processed work
  • Update/verify entries in the electronic repository
  • Prepare and send email notifications to project review team
  • Process electronic submissions, including coding and data entry into DARRTS
  • Research complex problems and provide detailed resolutions
  • Update tracking databases to ensure completeness and timeliness of tasks performed
  • Respond to client requests
  • Process notifications and conduct data cleanup tasks
  • Develop and maintain documentation, including SOPs and technical documents

Requirements

The qualified candidate will have the following:

  • U.S. Citizenship.
  • Minimum of a high school diploma or equivalent.
  • Excellent organizational and interpersonal skills
  • Excellent communication skills
  • Excellent, proven computer skills required to perform the job requirements
  • Willingness to learn and participate in a team effort
  • Ability to sit, stand, bend, stretch, lean and lift 30 pounds as required when handling boxes of records.

(Candidates who reside in a qualified HUBZone area are a plus. Please confirm qualified HUBZone eligibility by accessing the HUBZone Map: (https://maps.certify.sba.gov)).

Benefits

Ivyhill has a comprehensive benefits package that includes Group Life Insurance and AD&D, healthcare, dental care, vision coverage, Supplemental Life Insurance and a 401(k) Plan.

Apply